Gynaecological Gender-affirming Surgeries - a Prospective Cohort Study

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Recruiting

CT.gov ID

NCT06098781

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomie, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth).

The main question it aims to answer are:

• What is the epxerienced effect of gynaecological gender-affirming surgeries

Participants will be asked to fillout a questionaire pre-opertively and 3,9 and 18 months post-operatively.

Condition or Disease	Intervention/Treatment	Phase
Gender Dysphoria

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

57 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Patient Reported Outcomes After Gynaecological Gender Surgeries

Actual Study Start Date :

Sep 2, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

Experienced effect on gender dysphoria [3& 9 months]
On a scale of -5 to +5 the experienced effect on gender dysphoria
Experienced effect on gender dysphoria measured by GCLS [9 & 18 months]
Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively

Secondary Outcome Measures

Experienced effect on psychological well being [3 & 9 months]
On a scale of -5 to +5 the experienced effect on psychological well being
Experienced effect on confidence [3& 9 months]
On a scale of -5 to +5 the experienced effect on confidence
Experienced effect on sexual experience [3& 9 months]
On a scale of -5 to +5 the experienced effect on sexual experience
Surgical satisfaction [3& 9 months]
Impact of health on satisfaction of life [3 & 9 months]
Comparison of Short Form Health Survey (SF12) pre- and postoperatively
Physical complaints post-operatively [3 & 9 months]
physical complaints (bleeding, discharge, abdominal/pelvic pain, difficulty sitting, difficulty peeing, climacterial other complaints)
Recovery time postoperatively [3 months]
Time to recovery of daily activities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

assigned female at birth
scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)

Exclusion Criteria:

age below 18 y/o
surgery combined with other surgeries (e.g. urethroplasty, metaidoioplasty)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC, Location VU Medical Center	Amsterdam		Netherlands

Sponsors and Collaborators

Amsterdam UMC, location VUmc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

J.A.F. Huirne, Professor, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT06098781

Other Study ID Numbers:

2020.332

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by J.A.F. Huirne, Professor, Amsterdam UMC, location VUmc

patient-reported outcome measure

Additional relevant MeSH terms:

Gender Dysphoria

Study Results

No Results Posted as of Oct 25, 2023